GLYCERYL TRINITRATE TABLETS BP 600 MICROGRAMS

Transcript

Glyceryl Trinitrate tablets
500micrograms and 600micrograms
Read all of this leaflet carefully before you
start taking this medicine because it contains
important information for you.
Always take this medicine exactly as described
in this leaflet or as your doctor or pharmacist has
told you.
• Keep this leaflet. You may need to read it
again.
• Ask your pharmacist if you need more
information or advise.
• If you get any side effects, talk to your doctor
or pharmacist. This includes any possible side
effects not listed in this leaflet.

Index
1 What Glyceryl Trinitrate tablets are
and what they are used for
2 What you need to know before you
take
3 How to take Glyceryl Trinitrate
Tablets
4 Possible side effects
5 How to store Glyceryl Trinitrate
Tablets
6 Contents of the pack and other
information
1 What Glyceryl Trinitrate tablets are
and what they are used for

Glyceryl Trinitrate belongs to a group of medicines
called nitrate vasodilators. These medicines work
by relaxing the blood vessels of the heart. This
reduces the strain on the heart by making it easier
to pump blood.
Glyceryl Trinitrate tablets BP may be used to:
• prevent or stop chest pain caused by angina
pectoris
• stop spasms in the blood vessels of the heart.

2 What you need to know before you
take

Do not take Glyceryl Trinitrate tablets if you:

• are allergic (hypersensitive) to glyceryl trinitrate,
nitrates or any of the ingredients in the tablet.
An allergic reaction may include a rash, itching,
difficulty breathing or swelling of the face, lips,
throat or tongue (see section 6).
• have anaemia.
• have raised pressure in your head including
that caused by an accident to your head or
bleeding on the brain, causing painful eyes,
changes in vision and a bad headache especially
behind the eyes.
• have increased pressure in the eye (glaucoma).

• are taking sildenafil (Viagra) or similar medicines
(such as tadalafil or vardenafil) used for the
treatment of erection problems.

Warnings and precautions

Talk to your doctor or pharmacist before
taking Glyceryl Trinitrate tablets if you have:

• severe liver or kidney problems
• an under active thyroid gland
• had a recent heart attack
•
low body temperature (hypothermia)
• poor nutrition due to an unbalanced diet or
digestion problems (malnutrition)
• abnormally low levels of oxygen in the blood
(hypoxaemia)
• very low blood pressure, low blood volume
or conditions that lower blood volume in the
heart
• any of the following heart conditions: narrowing
of heart valves, inflammation of the heart, build
up of fluid around the heart or heart failure
• disease of the blood vessels supplying the brain
(cerebrovascular disease).

Other medicines and Glyceryl Trinitrate
Tablets

Tell your doctor or pharmacist if you are taking,
have recently taken or might take any other
medicines, including medicines obtained without
a prescription. Especially:
•
sildenafil (Viagra), tadalafil (Cialis) or
vardenafil (Levitra) used to treat erection
problems
•
heparin used to thin the blood
• n-acetylcysteine used in paracetamol overdose
• long acting nitrates (isosorbide dinitrate,
isosorbide mononitrate)
• medicines used to treat high blood pressure
• medicines that can cause dry mouth
(amitriptyline, disopyramide, atropine and
propantheline, tricyclic antidepressants)
•
apomorphine used to treat Parkinson’s disease.
• medicines used to treat migraine (ergot
alkaloids)

Glyceryl Trinitrate tablets with alcohol

You are advised not to drink alcohol with Glyceryl
Trinitrate tablets, as some of the effects of this
medicine are increased.

Pregnancy and breast feeding

If you are pregnant, planning to become pregnant
or breast feeding, ask your doctor or pharmacist for
advice before taking this medicine.

Driving and using machines

As glyceryl trinitrate can cause dizziness you
should make sure you are not affected before
driving or operating machinery, especially if taken
with alcohol.

Glyceryl Trinitrate Tablets contain lactose
If you have been told you have an intolerance to
some sugars, contact your doctor before taking
this medicine, as it contains lactose.

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AAAI2227

130x210 Leaflet Reel Fed Profile (BST)

Glyceryl Trinitrate All Strengths Tablets PIL UK
item no:

AAAI2227

dimensions: 130 x 210

print proof no:

1

pharmacode:

origination date: 9.9.15
approved for print/date

originated by:

min pt size:

db
Technical Approval

revised by:

date sent:

n/a

approved:

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Actavis UK

Glyceryl Trinitrate Tablets 500 &
600mg x 100’s (UK)

1. black

JDE No.:

2.
3.
4.

7 pt

revision date:

supplier:

colours/plates:

50868502

Dimensions: 130x210 (Reel Fed)
Component: Leaflet for Bottles

5.

Pharmacode: 2769

6.

Date Sent:
10/08/15
Technologist: R.Wrey

Non Printing Colours
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Technically Approved

2.
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* Please note that only Actavis Global Artwork Studios are permitted to make changes to the above
artwork. No changes are permitted by any 3rd party other than added notes and mark ups for
required changes.

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3 How to take Glyceryl Trinitrate Tablets
Always take Glyceryl Trinitrate tablets exactly as
your doctor has told you. If you are not sure, check
with your doctor or pharmacist.
Do not swallow the tablets.
Doses:
Adult: Take the tablets sat down when taking to
stop angina pectoris. 1 tablet should be placed
under the tongue and allowed to dissolve slowly;
this dose should be repeated after 5 minutes if
symptoms are not relieved. If pain persists after
a total of 3 doses in 15 minutes you should seek
medical advice immediately.
Older people: When taking to prevent or stop
angina pectoris take the tablets sat down to reduce
possible fainting or low blood pressure.
Your doctor will change the dose to suit your
condition. If you notice that your tablets are not
working as well at relieving pain as they have done,
contact your pharmacist or doctor. If you need more
tablets than before to help, tell the doctor who will
advise what to do.

If you take more Glyceryl Trinitrate Tablets
than you should

If you (or someone else) swallow a lot of
tablets at the same time, or you think a child
may have swallowed any contact your nearest
hospital casualty department or tell your doctor
immediately. Symptoms of an overdose include
being sick, restlessness, low blood pressure, fainting,
blueness of the skin, methaemoglobin in the blood,
breathing difficulties, lack of oxygen in tissues, slow
heart beat and mental illness.

4 Possible side effects

Like all medicines, Glyceryl Trinitrate tablets can
cause side effects, although not everybody gets
them.
If any of the following serious side effects
happen, stop taking the medicine and tell
your Doctor immediately or go to your nearest
hospital:
Worsening of angina symptoms, chest pains,
hypoxaemia (difficulty breathing, increased rate
of breathing), methaemoglobinaemia (breathing
problems, headache, tiredness), difficulty breathing,
blue colouring of the lips, fingers or toes (cyanosis),
rapid (tachycardia) or slowed (bradycardia)
heartbeat, blindness in one eye, cerebral ischaemia
which may cause weakness in one arm or leg, or
weakness in one entire side of the body, difficulty
speaking, slurred speech, loss of coordination, loss
of consciousness
Other side effects:
Very common (may affect more than 1 in 10 people)
• throbbing headache
Common (may affect up to 1 in 10 people)
• spinning sensation, fall in blood pressure when
seated or standing up, dizziness, drowsiness
• weakness
Uncommon (may affect up to 1 in 100 people)
• fainting
• facial flushing
• feeling or being sick
• localised burning sensation
• tongue blistering
Rare (may affect up to 1 in 1,000 people)
• allergic skin reactions

50868502

Very rare (may affect up to 1 in 10,000 people)
• restlessness
• heartburn
• bad breath, itchy, flaky or red skin, skin rash
Not known (frequency cannot be estimated from
the available data)
• pain around the eye, changes in vision

Reporting of side effects

If you get any side effects, talk to your doctor,
pharmacist or nurse. This includes any possible side
effects not listed in this leaflet. You can also report
side effects directly via the Yellow Card Scheme at:
www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more
information on the safety of this medicine.

5 How to store Glyceryl Trinitrate
Tablets

Keep this medicine out of the sight and reach of
children.
The active medicine quickly evaporates from
the tablet and you should observe the following
conditions to ensure continued potency of the
tablets.
• If you do not use the tablets within 8 weeks of
first opening the bottle, obtain a fresh supply and
return the old tablets to your pharmacist. (Fresh
tablets should produce a slight burning sensation
when placed under the tongue; if this does not
occur, obtain a fresh supply). In any event do not
use the tablets after the expiry date shown.
• Your Glyceryl Trinitrate tablets will be in a glass
airtight container with a foil-lined cap. Keep them
in this.
• After each use close the bottle cap tightly.
• Do not put cotton wool, other medicines, or
anything else in the bottle with the tablets.
• Store the tablets below 25oC in a dry place,
protected from light. If you need to carry them
with you do not carry them close to your body,
rather in a purse, wallet or handbag.
Do not use Glyceryl Trinitrate tablets after the expiry
date stated on the bottle. The expiry date refers to
the last day of that month.
Medicines should not be disposed of via wastewater
or household waste. Ask your pharmacist how to
dispose of medicines no longer required. These
measures will help to protect the environment.

6 C
ontents of the pack and other
information

What Glyceryl Trinitrate tablets contain

• The active substance (the ingredient that makes
the tablets work) is glyceryl trinitrate BP. Each
tablet contains either 0.525mg or 0.630mg of the
active ingredient Glyceryl trinitrate 2% adsorbate
which is equivalent to 500micrograms and
600micrograms of Glyceryl trinitate.
• The other ingredients are lactose, stearic acid,
magnesium stearate, colloidal silicon dioxide,
mannitol and acacia.

What Glyceryl Trinitrate tablets look like
and contents of the pack
Glyceryl Trinitrate are white, circular, uncoated
tablets.
Pack size is 100.
Marketing Authorisation Holder and Manufacturer
Actavis, Barnstaple, EX32 8NS, UK
This leaflet was last revised in
August 2015.

Actavis, Barnstaple, EX32 8NS, UK

AAAI2227

130x210 Leaflet Reel Fed Profile (BST)

Glyceryl Trinitrate All Strengths Tablets PIL UK
item no:

AAAI2227

dimensions: 130 x 210

print proof no:

1

pharmacode:

origination date: 9.9.15
approved for print/date

originated by:

min pt size:

db
Technical Approval

revised by:

date sent:

n/a

approved:

n/a

Actavis UK

Glyceryl Trinitrate Tablets 500 &
600mg x 100’s (UK)

1. black

JDE No.:

2.
3.
4.

7 pt

revision date:

supplier:

colours/plates:

50868502

Dimensions: 130x210 (Reel Fed)
Component: Leaflet for Bottles

5.

Pharmacode: 2769

6.

Date Sent:
10/08/15
Technologist: R.Wrey

Non Printing Colours
1. profile

Technically Approved

2.
3.

* Please note that only Actavis Global Artwork Studios are permitted to make changes to the above
artwork. No changes are permitted by any 3rd party other than added notes and mark ups for
required changes.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.